GoKawiilScience Corporation, a startup developing novel brain-computer interfaces (BCI), won approval from Europe’s medical device regulator to begin selling a device that restores vision lost from age-related macular degeneration.
The company said the device, called PRIMA, also received a designation from the US Food and Drug Administration that is the first step toward an expedited regulatory review, which could see the device used to treat two rare kinds of blindness.
Millions of people around the world suffer from age-related macular degeneration, which destroys the light-sensitive cells at the back of the eyes, making it difficult to read and recognize faces.
To use the device, patients suffering from this loss of vision undergo an hour-long outpatient procedure that plants a small chip in back of their eye. Then they wear camera-equipped glasses that transmit a view of the world to the chip. Max Hodak, Science Corp.’s founder and CEO, says the product gives functional vision to people who have lost it.
“One of our patients in France finished a 300-page novel a little while ago, and sent us the book,” Hodak told TechCrunch. “We have a sketch on the wall [that] one of our patients drew of the Sydney Opera House. There are videos of patients playing crossword puzzles and filling in Sudoku.”
Hodak is known as the co-founder and former president of Neuralink, Elon Musk’s BCI startup. He left in 2021 to start Science Corp., with plans to develop a novel BCI based on a hybrid of silicon chips and living cells. But first, the company had to prove out its processes and develop a sustainable business.
“The thing that the space needs is a company making $100 million a year of revenue,” Hodak said. “There’s this risk that the whole thing enters a winter, and so we think it’s important to build a sustainable business as we develop these longer-term technologies.”
Hodak and his colleagues believe that sustainable business will be restoring vision to the blind, specifically patients whose conditions stem from problems with the light-detecting cells at the back of the eye. After exploring multiple approaches, they determined that Pixium, a French company that developed the PRIMA technology, had the right path forward and acquired the firm in 2024. Science Corp. used its internal platform to build out the documentation and evolve the product to prepare it for regulatory approval and commercialization.
Each PRIMA device is expected to cost in the hundreds of thousands of dollars; Science Corp. and its medical partners in Europe are currently in discussion with healthcare providers over reimbursement. The company is laying the groundwork to begin offering PRIMA in Germany, where its clinical trials were held, and could see the first procedure in September.
Science Corp. expects to continue improving the vision capabilities of PRIMA with a new chip, and the form factor of its glasses, which currently require a battery-pack to operate. The goal is to offer something like Meta’s AR glasses, but the power and compute requirements for PRIMA are more significant.
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